Root Cause Analysis: What can be found in FDA Warning Letters?

corrective action and preventive action (CAPA) according to your procedure until after FDA cited your firm.
Bell International Laboratories, USA (February 2024)

"Your quality unit (QU) lacked adequate control over your over-the-counter (OTC) drug manufacturing operations and failed to ensure that you had adequate procedures. For example, your QU failed to ensure:
- Adequate investigations into non-conformances (21 CFR 211.192).
- Adequate investigations into complaints (21 CFR 211.198(a))."
"Your response is inadequate because you did not address how you will ensure that investigations contain adequate root cause determinations, corrective action and preventive action (CAPA), and effectiveness checks".
Sichuan Deebio Pharmaceutical, China (February 2024)

"Your firm's quality unit (QU) failed to (...) extend product quality complaint investigations to other batches or APIs potentially associated with the root cause, failure, or deviation".
Cosmetic Specialty Labs, USA (February 2024)

"For example, your QU failed to ensure: (...) Thorough investigations into out-of-specifications (OOS) results, deviations, and other discrepant results are performed per an adequate written and approved procedure".
Antaria Pty. Ltd., Australia (March 2024)

"The root causes were not clearly defined nor adequately documented"
"you failed to describe a holistic review of all investigations, root cause analyses and corrective actions for adequacy"
"ensure that all other laboratory methods vulnerable to the same or similar root cause are identified for remediation".
Cohere Beauty, USA (April 2024)

"Your investigation only focused on reviewing formulation and customer complaints but did not adequately investigate the root cause".
Natco Pharma, India (April 2024)

"Your firm's investigations into unexplained discrepancies were inadequate. Your quality unit (QU) failed to thoroughly investigate all finished product batches and components associated with unexplained discrepancies."
"You concluded your investigations without a root cause determination supported by evidence or initiating CAPA."

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